CN112638294B - Medical device for percutaneous opening procedure - Google Patents

Abstract

A medical device (1) for use in a percutaneous opening procedure, in particular for use in a percutaneous opening procedure on an upper or lower limb, such as percutaneous carpal tunnel opening or percutaneous A1 pulley opening. The medical device (1) comprises a handle portion (2) and an elongated shaft member (5), the handle portion (2) being designed to allow manipulation, orientation and manipulation of the medical device (1), the elongated shaft member (5) being fixed to the handle portion (2) and extending in a defined plane (P0). A first portion of the elongate shaft member (5) extends away from the handle portion (2) in a first direction (a 1) within a defined plane (P0), and a second portion of the elongate shaft member (5) downstream of the first portion is bent and/or folded within the defined plane (P0). The free end of the elongated rod member (5), at the extremity (5A) of the second portion, is shaped as an inclined end (6) presenting an inclined surface (6A), the inclined end (6) being designed to act as a cutting device for cutting tissue, the inclined surface (6A) being inclined with respect to a defined plane (P0).

Description

Medical devices used in percutaneous release procedures

Technical Field

The present invention generally relates to medical devices for percutaneous release procedures, particularly for percutaneous release procedures of the upper or lower extremities, such as, but not limited to, percutaneous carpal tunnel release and percutaneous A1 pulley release. The present invention is also applicable to other release procedures, such as, but not limited to, tenolysis, tenotomy, tenotomy-lengthening, aponeurosis, neurolysis, and neurotomy.

Background of the Invention

Carpal tunnel syndrome (CTS) and trigger finger syndrome (TFS) can be conveniently treated with surgical release procedures. These surgical release procedures are typically performed using a simple puncture needle or a more complex hook knife or push knife. This medical device can also be used for other surgical release procedures on the upper or lower extremity, such as for the treatment of Morton's neuroma, tarsal tunnel release, De Crevan's syndrome, epicondylalgy, shoulder surgery, and similar release procedures, the list of which is not meant to be exhaustive.

US Patent No. 5,507,800A discloses a carpal tunnel pliers (carpaltunnel tome) for performing carpal tunnel release surgery, the pliers include a handle portion attached to a rod having a head or cutting head integrally formed thereon. The head includes a blade having a cutting edge, and the two sides of the cutting edge are defined by blunt protrusions. In the carpal tunnel release surgical procedure, the medical instrument is maintained in such a configuration that the blade is placed substantially vertically, wherein the blunt protrusions on the lower and upper sides of the blade span the ligament. Then, the surgeon uses the medical instrument as a push knife to gradually cut the ligament. The size and configuration of the above-mentioned carpal tunnel pliers are such that as a preparatory step, the carpal tunnel release surgery requires an incision of about 1 to 2 cm on the palm side of the patient's hand, and a surgical retractor is used for sharp dissection to expose a portion of the ligament. Only in this way can the carpal tunnel pliers be inserted into the wound, wherein the exposure by the surgical retractor is maintained, and the carpal tunnel pliers are pushed to cut the ligament.

Therefore, a disadvantage of the carpal tunnel clamp disclosed in US Pat. No. 5,507,800A is that the associated surgical procedure is not strictly percutaneous and still requires a relatively large incision on the palmar side of the patient's hand, which requires corresponding sutures to close the incision after the surgical procedure.

U.S. Patent No. 5,029,573A discloses a system for endoscopic surgery, which is used to perform carpal tunnel release surgery. According to the patent publication, a probe knife, a triangular cutting instrument, and a relatively large-sized retrograde cutting instrument are used in combination with a trocar and a sheath as a guide member, first inserted under the carpal ligament, which requires an entry incision and an exit incision of about 1 to 2 cm to be performed both on the patient's wrist and on the palm side of the patient's hand. In addition, a special hand rest is required to fix the patient's hand in an overextended position to allow the trocar and sheath to be fully inserted through the carpal tunnel. The trocar and sheath are initially inserted through the patient's hand and carpal tunnel from the wrist side to the palm side. Once the trocar and sheath are fully inserted, the trocar is withdrawn, and then the endoscope is inserted into either open end of the sheath. The probe knife, triangular cutting instrument, and retrograde knife are then used in sequence and inserted through the free end of the sheath to perform the release of the carpal ligament.

Therefore, the solution disclosed in US Pat. No. 5,029,573A has the disadvantage that the associated surgical procedure is also not strictly percutaneous and requires two relatively large incisions on the palmar side of the patient's hand and wrist to allow the insertion of the trocars, which requires corresponding sutures to close the associated incisions after the surgical procedure. The surgical procedure also requires the use of a set of various instruments to complete the release procedure.

US Pat. No. 8,603,124 B1 discloses an improved surgical knife for ultrasound-assisted carpal tunnel surgery, which is used in combination with a trocar to perform carpal tunnel release.

Percutaneous release procedures can be performed using a simple needle. However, this solution is not satisfactory because the release procedure is not easy to perform and is potentially dangerous to adjacent structures.

U.S. Patent No. 5,782,850A discloses a medical device (also called a "trigger knife") for treating trigger finger syndrome (TFS), the medical device having an operating portion, the operating portion including a tapered cord tip front end, the tapered cord tip front end having a first tip pointing forward at the front end, a second tip pointing backward relative to the first tip, and a transverse groove-shaped depression, the transverse groove-shaped depression having a hook-shaped cutting edge extending downward and backward from the second tip and along the entire length of the second tip. Percutaneous release of the A1 pulley can be performed by the above medical device, that is, without any incision at the entry point, the medical device is used in an antegrade manner, from the proximal edge to the distal edge of the pulley, to gradually cut the pulley.

The shortcoming of the medical instrument disclosed in US Pat. No. 5,782,850A is that its construction is still relatively complicated. In addition, the construction of the medical instrument makes the groove-shaped depression and the hook-shaped cutting edge extending therein possibly cause undesirable damage to surrounding tissues and structures, especially during the extraction of the medical instrument.

While these medical devices may be quite satisfactory, there remains a need for improved solutions, particularly solutions that allow for minimally invasive surgical release procedures, i.e., in a truly percutaneous manner, and prevent undesirable damage to surrounding tissue and structures during insertion and/or withdrawal of the medical device.

SUMMARY OF THE INVENTION

A general object of the present invention is to provide an improved medical device for percutaneous release procedures, in particular for percutaneous release procedures on the upper or lower extremities, such as percutaneous carpal tunnel release or percutaneous A1 pulley release, as well as other percutaneous release procedures for treating conditions or syndromes such as those listed in the introductory part of this specification.

According to a first aspect of the invention, the overall objective is achieved thanks to the solution defined herein, i.e. a medical device for percutaneous release procedures, comprising a handle portion and an elongated rod member, the handle portion being designed to allow the medical device to be handled, oriented and manipulated by a surgeon, the elongated rod member being fixed to the handle portion and extending substantially within a defined plane. A first portion of the elongated rod member extends substantially in a first direction away from the handle portion within the defined plane, and a second portion of the elongated rod member, located downstream of the first portion, is bent and/or folded within the defined plane. In addition, the free end of the elongated rod member, at the end of the second portion, is shaped as an inclined end presenting an inclined surface, the inclined end being designed to be used as a cutting device for severing tissue, the inclined surface being inclined relative to the defined plane.

Advantageous embodiments of the invention form the subject matter of the dependent claims and are discussed below.

According to a preferred embodiment of the present invention, the inclination angle of the plane including the inclined surface relative to the defined plane is about 10° to 40°. Even more preferably, the inclination angle is about 15° to 30°.

According to an advantageous embodiment of this first aspect of the invention, the inclined end presents at least two inclined surfaces with different inclination angles. These at least two inclined surfaces help to locate and orient the end of the medical instrument under ultrasound examination, because the inclined surfaces will generate different ultrasonic echoes or signals due to the different inclination angles.

According to another embodiment of the first aspect of the invention, at the extreme distal end of the beveled end, the leading edge of the beveled end is provided with at least one side bevel which defines a cutting edge.

In the aforementioned context, the elongated rod member may in particular be solid and non-hollow.

According to a particularly preferred embodiment of this first aspect of the invention, the elongated rod member extends along a generatrix, and the transverse width of the elongated rod member measured at any point along the generatrix up to and including the end of the second portion does not exceed 2 mm. This results in the elongated rod member having a particularly thin configuration, which facilitates the insertion and withdrawal of the medical device without causing damage to surrounding tissue or structures.

According to a second aspect of the invention, the above-mentioned general object is also achieved due to the solution defined herein, i.e. a medical device for percutaneous release procedures, which comprises a handle portion and an elongated rod member, the handle portion being designed to allow the medical device to be operated, oriented and manipulated by a surgeon, the elongated rod member being fixed to the handle portion and extending substantially within a defined plane. A first portion of the elongated rod member extends substantially in a first direction away from the handle portion within the defined plane, and a second portion of the elongated rod member, located downstream of the first portion, is bent and/or folded within the defined plane. Furthermore, at the end of the second portion, the free end of the elongated rod member is flattened to form a flattened portion, which is designed to be used as a cutting device for severing tissue, and which extends substantially parallel to the defined plane.

According to a preferred embodiment of this second aspect of the invention, the flattened portion extends substantially within a defined plane.

Preferably, the flattened portion is configured to present a tapered leading edge, which acts as a cutting edge.

The flattened portion may in particular present a thickness of less than 0.5 mm, said thickness being measured perpendicularly to the defined plane.

The flattened portion may also present a width of no more than 2.5 mm, the width being measured in the defined plane.

According to a particularly preferred embodiment of this second aspect of the invention, the elongated rod member extends along the generatrix, and the transverse width of the elongated rod member measured at any point along the generatrix up to but not including the end of the second portion does not exceed 2 mm. This also results in the elongated rod member having a particularly thin construction, which facilitates the insertion and withdrawal of the medical device without causing damage to surrounding tissues or structures.

In the foregoing context, the elongate rod member preferably comprises a hollow tubular member, and the flattened portion is a flattened free end of the hollow tubular member.

Further embodiments of the invention which are applicable in the context of both the above-mentioned first and second aspects of the invention form the subject matter of the additional dependent claims and are discussed below.

Advantageously, at the end of the second portion, the end of the elongated rod member extends substantially perpendicular to the first direction. In particular, the end of the elongated rod member may extend along a second direction, the second direction forming an angle comprised between 80° and 120° with respect to the first direction.

Preferably, the first portion of the elongated rod member is a substantially rectilinear portion.The first portion of the elongated rod member may in particular have a length of about 30 mm to 60 mm.

According to an embodiment of the present invention, the second part includes at least one curved portion, the at least one curved portion extending at an angle exceeding 30°. According to a first variant of the embodiment, the second part includes a single curved portion, the single curved portion extending at an angle exceeding 60°, and the radius of curvature of the curved portion is preferably about 30mm to 45mm. In this case, the end of the elongated rod member, at the end of the second part, can extend in particular along a second direction perpendicular to the first direction. According to a second variant of the embodiment, the second part includes a plurality of (especially three) curved portions, each extending at an angle not exceeding 40°. In this case, the plurality of curved portions can be separated in particular by substantially straight portions, preferably the substantially straight portions having a length of about 15mm to 25mm.

According to a particularly advantageous embodiment of the invention, the elongated rod member is provided with a plurality of markings, such as embossings, which are designed to be discernible under ultrasonic inspection. These markings are preferably distributed over the second portion of the elongated rod member. Furthermore, the size and/or distribution of the markings along the elongated rod member may advantageously be non-uniform.

Advantageously, the handle portion of the medical device may be provided with a visible marking, such as a laser marking, preferably provided on an inner face of the handle portion, the marking being oriented in the same direction as the second portion of the elongate rod member.

Preferably, the cross-section of the elongated rod member has an area of no more than 5 mm ² . Even more preferably, the cross-section of the elongated rod member has an area of no more than 2 mm ² . The diameter of the elongated rod member upstream of the distal end may in particular be about 1 to 2 mm.

According to a particularly preferred embodiment of the invention, the elongated rod member has a substantially circular cross section upstream of the distal end.

The use of the medical device of the invention is also claimed for the purpose of performing a percutaneous release procedure on the upper or lower limb, in particular for the purpose of performing a percutaneous carpal tunnel release or for the purpose of performing a percutaneous A1 pulley release.

Preferably, the medical device of the invention is used for the purpose of performing a percutaneous release procedure, which is performed with the aid of an ultrasound examination. The use of the medical device of the invention in combination with an ultrasound probe is also claimed. In this case, the medical device can in particular be a medical device according to the above description having an elongated rod member provided with a plurality of markings, which are utilized for the purpose of orienting the medical device in a percutaneous release procedure. In this regard, the orientation of the medical device can in particular be automatically detected in the ultrasound image. Advantageously, a virtual representation of the medical device can also be superimposed on the ultrasound image in real time.

BRIEF DESCRIPTION OF THE DRAWINGS

Other characteristics and advantages of the invention will appear more clearly on reading the following detailed description of embodiments of the invention, which are provided by way of non-limiting examples only and are illustrated by the accompanying drawings, in which:

1 is a perspective view of a medical device according to a first embodiment of the present invention, which is particularly suitable for use in percutaneous carpal tunnel release in the treatment of carpal tunnel syndrome;

FIG2 is a side view of the medical device of FIG1 , viewed along the x-axis of the Cartesian coordinate system x-y-z reproduced in FIG1 , wherein the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG3 is another side view of the medical device of FIG1 as seen along the x-axis;

FIG4 is a top view of the medical device of FIG1 as seen along the z-axis;

FIG5 is a rear view of the medical device of FIG1 as seen along the y-axis;

FIG6 is an enlarged view of the distal end of the medical device of FIG1 , identified by detail A in FIG5 ;

FIG7 is a perspective view of the handle portion of the medical device of FIG1;

FIG8 is a side view of the handle portion of FIG7 with visual markings provided on the handle portion;

FIG9 is another side view of the handle portion of FIG7 obtained from another angle;

FIG10 is a front view of the handle portion of FIG7 with the handle portion secured to an elongated rod member of the medical device;

11 is a perspective view of a medical device according to another embodiment of the present invention, which is particularly suitable for use in A1 pulley release in the treatment of trigger finger syndrome;

FIG12 is a side elevational view of the medical device of FIG11 , viewed along the x-axis of the Cartesian coordinate system x-y-z reproduced in FIG11 , wherein the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG13 is another side view of the medical device of FIG11 as seen along the x-axis;

FIG14 is a front view of the medical device of FIG11 as seen along the y-axis;

FIG15 is an enlarged view of the distal end of the medical device of FIG11 , identified by detail B in FIG13 ;

Fig. 16 is a cross-sectional view of the tip of the medical device of Fig. 11 taken along the cross section C-C reproduced in Fig. 15;

FIG17 is a perspective view of the handle portion of the medical device of FIG11;

FIG18 is a side view of the handle portion of FIG17;

FIG19 is another side view of the handle portion of FIG17 obtained from a different angle;

FIG20 is a front view of the handle portion of FIG17 with the handle portion secured to an elongated rod member of the medical device;

21A is a top view of the end of the medical device, showing the structure of the inclined end of the medical device according to another embodiment of the present invention, which structure can also be applied to the medical device of FIGS. 1 to 20 ;

FIG21B is a side view showing the configuration of the angled end of the medical device of FIG21A;

FIG22A is a cross-sectional view of the distal end of the elongated rod member of the medical device of FIGS. 21A and 21B , taken along the cross-section D-D reproduced in FIGS. 21A and 21B (upstream of the angled end);

FIG22B is a cross-sectional view of the distal end of the elongated rod member of the medical device of FIGS. 21A and 21B , taken along cross section E-E reproduced in FIGS. 21A and 21B (through a first portion of the angled end);

FIG22C is a cross-sectional view of the distal end of the elongated rod member of the medical device of FIGS. 21A and 21B , taken along cross section F-F reproduced in FIGS. 21A and 21B (through the second portion of the angled end);

FIG22D is a front view of the distal end of the elongated rod member of the medical device of FIGS. 21A and 21B ;

FIG23 is a side view of a variation of the medical device of FIGS. 1 to 10 , as viewed along the x-axis of a Cartesian coordinate system x-y-z, in which the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG24 is a top view of the medical device of FIG23 as seen along the z-axis;

FIG25 is a rear view of the medical device of FIG23 as seen along the y-axis;

FIG26 is an enlarged view of the distal end of the medical device of FIG23 as seen along the x-axis;

Fig. 27 is a cross-sectional view of the tip of the medical device of Fig. 23 taken along the cross section G-G reproduced in Fig. 26;

FIG28 is a side view of a variation of the medical device of FIGS. 11 to 20 , as viewed along the x-axis of a Cartesian coordinate system x-y-z, in which the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG29 is a front view of the medical device of FIG28 as seen along the y-axis;

FIG30 is an enlarged view of the distal end of the medical device of FIG28 as seen along the x-axis;

Fig. 31 is a cross-sectional view of the tip of the medical device of Fig. 28, taken along the cross section H-H reproduced in Fig. 30;

FIG32 is a side view of a medical device according to another embodiment of the present invention, viewed along the x-axis of a Cartesian coordinate system x-y-z, wherein the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG33 is a top view of the medical device of FIG32 as seen along the z-axis;

FIG34 is a rear view of the medical device of FIGS. 23 and 24 , taken along the y-axis;

FIG35A is a side view of the elongated rod member of the medical device of FIGS. 32 to 34 before it is formed and flattened;

FIG35B is a top view of the elongated rod member of FIG35A;

Fig. 35C is a cross-sectional view of the elongated rod member of Figs. 35A and 35B taken along the cross section I-I reproduced in Fig. 35B;

FIG36A is a side view of the elongated rod member of FIGS. 35A to 35C after it has been formed and before the distal end of the elongated rod member has been flattened;

FIG36B is a rear view of the elongated rod member of FIG36A;

FIG37A is a side view of the elongated rod member of FIGS. 36A and 36B after the distal end of the elongated rod member is flattened;

FIG37B is a rear view of the elongated rod member of FIG37A;

Fig. 37C is an enlarged view of the flattened end of the elongated rod member of Fig. 37A, identified by detail J in Fig. 37A;

FIG38 is a side view of a medical device according to another embodiment of the present invention, viewed along the x-axis of a Cartesian coordinate system x-y-z, wherein the elongated rod member of the medical device extends substantially within a defined plane (parallel to a vertical plane formed by the y-axis and the z-axis);

FIG39 is a top view of the medical device of FIG38 as seen along the z-axis;

FIG40 is a rear view of the medical device of FIGS. 38 and 39 , taken along the y-axis;

FIG41A is a side view of the elongated rod member of the medical device of FIGS. 38 to 40 prior to being formed and flattened;

FIG41B is a top view of the elongated rod member of FIG41A;

FIG42A is a side view of the elongated rod member of FIGS. 41A and 41B after it has been formed and before the distal end of the elongated rod member has been flattened;

FIG42B is a rear view of the elongated rod member of FIG42A;

FIG43A is a side view of the elongated rod member of FIGS. 42A and 42B after the distal end of the elongated rod member is flattened;

FIG43B is a rear view of the elongated rod member of FIG43A;

Fig. 43C is an enlarged view of the flattened end of the elongated rod member of Fig. 43A identified by detail K in Fig. 43A;

44A and 44B are schematic diagrams showing the medical device of FIGS. 32 to 37A-37C used to release the transverse carpal ligament (TCL) under ultrasound guidance prior to insertion of the device;

45A and 45B are schematic diagrams showing the medical device of FIGS. 32 to 37A-37C during insertion of the device;

46A to 46C are schematic diagrams showing the medical device of FIGS. 32 to 37A-37C during the TCL being cut;

FIG47 is a schematic diagram showing the withdrawal of the instrument of FIGS. 32 to 37A-37C after the release of the TCL is completed;

48A and 48B are schematic diagrams showing the medical device of FIGS. 39 to 43A-43C being used to release the A1 pulley under ultrasound guidance during insertion of the device;

49A and 49B are schematic diagrams showing the medical device of FIGS. 39 to 43A-43C during cutting of the A1 pulley; and

FIG. 50 is a schematic diagram showing the withdrawal of the instrument of FIGS. 39 to 43A-43C after the release of the A1 pulley is completed.

Specific embodiments of the present invention

The invention will be described in conjunction with various illustrative embodiments. It should be understood that the scope of the invention includes all combinations and sub-combinations of features of the medical devices disclosed herein.

As described herein, when two or more parts or components are described as being connected, attached, fixed or coupled to each other, they may be connected, attached, fixed or coupled to each other directly or through one or more intermediate parts.

With reference to Figures 1 to 10, a first embodiment of a medical device according to the present invention, indicated by reference numeral 1, is shown, which is particularly suitable for percutaneous carpal tunnel release in the treatment of carpal tunnel syndrome (CTS). A variation of the first embodiment is further shown in Figures 23 to 27, indicated by reference numeral 1*.

Referring to Figures 11 to 20, another embodiment of a medical device according to the present invention, indicated by reference numeral 10, is shown, which is particularly suitable for percutaneous A1 trochlear release in the treatment of trigger finger syndrome (TFS). A variation of this second embodiment is further shown in Figures 28 to 31, indicated by reference numeral 10*.

Additional embodiments of the present invention are discussed with reference to Figures 32 to 43A-43C. Figures 32 to 37A-37C illustrate additional embodiments of a medical device 100 that is particularly suitable for percutaneous carpal tunnel release in the treatment of carpal tunnel syndrome (CTS), while Figures 38 to 43A-43C illustrate another embodiment of a medical device 110 that is particularly suitable for percutaneous A1 pulley release in the treatment of trigger finger syndrome (TFS).

All embodiments have a number of common features, including a handle portion 2, 20, 200, 200*, designed to allow the medical device to be manipulated, oriented and steered by a surgeon; and an elongated rod member 5, 50, 5*, 50*, 105, 150, which is fixed to the handle portion 2, 20, 200, 200* and extends substantially in a defined plane represented by the reference numeral P0. With reference to the Cartesian coordinate system x-y-z reproduced in the drawings, it is assumed that this defined plane P0 is a vertical plane (parallel to the vertical plane formed by the y-axis and the z-axis).

As shown in the figures (see in particular Figures 3, 13, 23, 28, 32 and 38), the first part of the elongated rod member 5, 50, 5*, 50*, 105, 150 extends away from the handle part 2, 20, 200, 200* in a defined plane P0, substantially along a first direction a1, a1' (i.e. parallel to the y-axis). The first part can be a substantially straight part. In addition, the second part of the elongated rod member 5, 50, 5*, 50*, 105, 150, which is located downstream of the first part, is bent and/or bent in the defined plane P0. The reference numeral GX in the accompanying drawings represents a generatrix, and the elongated rod member 5, 50, 5*, 50*, 105, 150 extends along the generatrix.

In addition, with respect to the embodiments shown in FIGS. 1 to 20 and 28 to 31, at the ends 5A, 50A, 5A*, 50A* of the second portion, the free ends of the elongated rod members 5, 50, 5*, 50* are formed as inclined ends 6, 60, 6*, 60*, which present inclined surfaces 6A (see FIGS. 5 and 6), 60A (see FIGS. 14 to 16), 6A* (see FIGS. 25 to 27), 60A* (see FIGS. 29 to 31), respectively. This inclined end 6, 60, 6*, 60*, respectively, is designed to be used as a cutting device for cutting off tissue, and the inclined surface 6A, 60A, 6A*, 60A* is inclined relative to the defined plane P0.

Preferably, the inclination angles θ1, θ2, θ1*, θ2* of the planes P, P', P*, P** (including the inclined surfaces 6A (see FIG. 6), 60A (see FIG. 16), 6A* (see FIG. 27), 60A* (see FIG. 31) relative to the defined plane P0) are approximately 10° to 40°, and even more preferably approximately 15° to 30°. In the examples of FIGS. 1 to 20 and 28 to 31, the inclination angles θ1, θ2, and θ2* are each approximately 30°, while in the examples of FIGS. 23 to 27, the inclination angle θ1* is approximately 15°.

21A-21B and 22A-22D show the configuration of an inclined end 600 at the end 500A of an elongated rod member 500 of a medical device according to another embodiment of the present invention. This structure is particularly suitable for the case of the above-mentioned medical device shown in FIGS. 1 to 20 .

Compared to the embodiment shown in FIGS. 1 to 20 (in which the inclined ends 6, 60 present a single inclined surface 6A, 60A), the inclined end 600 shown in FIGS. 21A-21B and 22A-22D presents at least two inclined surfaces 600A, 610A, which have different inclination angles θ3 and θ4 relative to a defined plane P0 (where reference numerals P" and P"' respectively denote associated planes including the inclined surfaces 600A, 610A). Since the inclined surfaces 600A, 610A generate different ultrasonic echoes or signals due to the different inclination angles θ3, θ4, this configuration is particularly advantageous for the purpose of positioning and orienting the tip 500A of the medical device under ultrasound examination.

In the case of the construction shown in Figures 21A-21B and Figures 22A-22D, the inclination angle θ3 of the plane P" including the inclined surface 600A relative to the defined plane P0 is approximately 15°, and the inclination angle θ4 of the plane P"' including the inclined surface 610A relative to the defined plane P0 is approximately 30°.

Figures 21A-21B and 22A-22D further illustrate another advantageous feature according to another embodiment of the present invention, which feature is also applicable to the case of the aforementioned medical device shown in Figures 1 to 20, regardless of the number of inclined surfaces. As shown in Figures 21A-21B and 22A-22D, at the extreme distal end of the inclined end 600, the leading edge of the inclined end 600 is provided with at least one side bevel 615A, 615B, which defines a corresponding cutting edge 620A, 620B. In the example of Figures 21A-21B and 22A-22D, two side bevels 615A and 615B are provided at the leading edge of the inclined end 600, resulting in the definition of two corresponding cutting edges 620A and 620B. It can be appreciated from the cross-sectional view with reference to Figure 22C that the provision of the side bevels 615A, 615B results in sharper cutting edges 620A, 620B, improving the ability to cut tissue. It should be understood that only one side bevel may be provided on one or the other side of the beveled end 600, rather than on both sides as shown.

In the illustrations of FIGS. 21A-21B and 22A-22D, the side slopes 615A, 615B are angled relative to the longitudinal axis of the end 500A of the elongated rod member 500 and form an angle γ1 of approximately 50°.

Similar features are embodied in the variants shown in Figures 23 to 27, where at the extreme distal end of the inclined end 6*, the leading edge of the inclined end 6* is provided with at least one side bevel 615A*, 615B*, which defines a corresponding cutting edge 620A*, 620B* (see Figure 26). In the example of Figures 23 to 27, two side bevels 615A* and 615B* are also provided at the leading edge of the inclined end 6*, resulting in the definition of two corresponding cutting edges 620A* and 620B*. The provision of the side bevels 615A*, 615B* similarly results in sharper cutting edges 620A*, 620B*, improving the ability to cut tissue. The side bevels 615A*, 615B* are also angled relative to the longitudinal axis of the end 5A* of the elongated rod member 5*, and form an angle γ1* of approximately 50°.

Figures 28 to 31 illustrate another embodiment of the aforementioned features, wherein at the extreme distal end of the inclined end 60*, the leading edge of the inclined end 60* is provided with at least one side bevel 615A**, 615B**, which defines a corresponding cutting edge 620A**, 620B** (see Figure 30). In the example of Figures 28 to 31, two side bevels 615A** and 615B** are again provided at the leading edge of the inclined end 60*, resulting in the definition of two corresponding cutting edges 620A** and 620B**. Compared with the previous example, the side bevels 615A** and 615B** are more pronounced, resulting in a larger angle configuration of the resulting cutting edges 620A**, 620B**, which also improves the ability to cut tissue. The side bevels 615A**, 615B**, and the resulting cutting edges 620A**, 620B** are angled relative to the longitudinal axis of the end 50A* of the elongated rod member 50*, and in this further example form an angle γ2* of approximately 90°.

With regard to the embodiments shown in FIGS. 32 to 37A-37C and 38 to 43A-43C, at the distal end 105A, 150A of the second portion, the free end of the elongated rod member 105, 150 is flattened to form a flattened portion 106, 160, which is designed to be used as a cutting device for cutting off tissue. The flattened portion 106, 160 extends substantially parallel to the defined plane P0. Preferably, as shown in FIGS. 33, 34, 37B, 39, 40 and 43B, the flattened portion 106, 160

Extends substantially within a defined plane P0.

In the illustrated example, the elongated rod member 105, 150 advantageously comprises a hollow tube member 105.1, 150.1, and the flattened portion 106, 160 is formed by flattening (eg, extruding) a free end of the hollow tube member 105.1, 150.1.

Figures 35A-35C illustrate the situation of the elongated rod member 105 before it is shaped and flattened to form the elongated rod member 105 shown in Figures 32 to 34 and Figures 37A-37C. More specifically, in the example shown, the elongated rod member 105 also includes an inner member 105.2 (especially referring to Figure 35C) inserted through a portion of the hollow tube member 105.1, leaving the free end 105.1A of the hollow tube member 105.1. In the state shown in Figures 35A-35C, the elongated rod member 105 is still substantially straight. For example, in this state (i.e. before being formed into the curved configuration shown in Figures 36A-36B), the total length La* of the elongated rod member 105 is about 110mm. The elongated rod member 105 is then formed into a bent configuration as shown in Figures 36A-36B, and the free end 105.1A of the hollow tube member 105.1 is then extruded to form the flattened portion 106 as shown in Figures 37A-37C.

Preferably, the free end 105.1A of the hollow tube member 105.1 is initially processed to be slightly curved and presents an inclined end with a defined inclination angle δ1, as shown in Figure 35A. For example, the inclination angle δ1 is selected to be about 9° here. Therefore, the extrusion of the free end 105.1A of the hollow tube member 105.1 leads to the formation of a flattened portion 106, which has a configuration as shown in Figures 37A-37C, with a characteristic tapered leading edge 106A as a cutting edge. Preferably, when measured perpendicular to the defined plane P0, the thickness t1 of the flattened portion 106 is reduced to less than 0.5mm, and when measured in the defined plane P0, the width w1 of the flattened portion 106 does not exceed 2.5mm. For example, the thickness t1 and the width w1 are 0.3mm and 2.3mm respectively here.

Figures 41A-41B illustrate the elongated rod member 150 before it is formed and flattened to form the elongated rod member 150 shown in Figures 38 to 40 and Figures 43A-43C. Although not shown, the elongated rod member 150 may also include an internal member inserted through a portion of the hollow tube member 150.1. In the state shown in Figures 41A-41B, the elongated rod member 150 is still substantially straight. For example, in this state (i.e., before being formed into a curved and bent configuration as shown in Figures 42A-42B), the total length La** of the elongated rod member 150 is approximately 85mm. The elongated rod member 150 is then formed into a curved and bent configuration as shown in Figures 42A-42B, and then the free end 150.1A of the hollow tube member 150.1 is extruded to form the free end 150.1A shown in Figures 43A-43C.

Flattened portion 160 .

Preferably, the free end 150.1A of the hollow tube member 150.1 is initially machined to present an inclined end with a defined inclination angle δ1', as shown in Figure 41A. In addition, two side bevels 150.2A, 150.2B forming an angle δ2' can be formed at the leading edge of the free end 150.1A of the hollow tube member 150.1, as shown in Figure 41B. By way of example, the inclination angle δ1' is selected here to be approximately 17.5°, while the angle δ2' formed by the side bevels 150.2A, 150.2B is approximately 52°. Therefore, the extrusion of the free end 150.1A of the hollow tube member 150.1 results in the formation of a flattened portion 160 having a configuration as generally shown in Figures 43A-43C, with a characteristic tapered leading edge 160A as a cutting edge. Preferably, the thickness t2 of the flattened portion 160 is also reduced to less than 0.5 mm when measured perpendicular to the defined plane P0, and the width w2 of the flattened portion 160 is also not more than 2.5 mm when measured in the defined plane P0. For example, the thickness t2 and the width w2 are here 0.4 mm and 1.8 mm, respectively.

Returning to the illustrations of FIGS. 1 to 20 , 23 to 31 , and 32 to 43A-43C , portions of the curved or bent second portion of the elongated rod member 5 , 50 , 5 * , 50 * , 105 , 150 can be used, in particular, as a fulcrum during surgery to facilitate severing of the desired tissue. In fact, portions of the curved or bent second portion can be appropriately used to support on underlying tissue or on additional instruments inserted for this purpose, thereby providing support for manipulation of the medical instrument during the severing procedure.

It will also be appreciated that the medical device of the present invention advantageously presents a minimal cross-section substantially corresponding to the cross-section of the elongated rod member, which greatly facilitates penetration of tissue with minimal disturbance both during insertion of the medical device into the area to be treated and during withdrawal of the medical device. Furthermore, the limited cross-sectional area of the elongated member (preferably not exceeding 5 mm ² , even more preferably less than 2 mm ² ) enables the surgical procedure to be performed in a truly percutaneous manner, without requiring any incision to be made at the entry point of the medical device, but only a puncture, which therefore heals without leaving any noticeable scar to the patient, much like an intravenous infusion.

Preferably, with reference to the embodiments shown in FIGS. 1 to 31 , the transverse width of the elongated rod member 5, 50, 500, 5*, 50* measured at any point along the generatrix GX up to and including the end 5A, 50A, 500A, 5A*, 50A* of the second portion does not exceed 2 mm. More specifically, in the example shown, the transverse width of the elongated rod member 5, 50, 500, 5*, 50* does not exceed the diameter D1, D1'. Similarly, with reference to the embodiments shown in FIGS. 32 to 43A-43C, the transverse width of the elongated rod member 105, 150 measured at any point along the generatrix GX up to but not including the end 105A, 150A of the second portion preferably does not exceed 2 mm. More specifically, in the example shown, the transverse width of the elongated rod member 105, 150, up to the flattened portion 106, 160, does not exceed the diameter D1*, D1**. In other words, the elongated rod member 5, 50, 500, 5*, 50*, 105, 150 has a particularly thin configuration, which facilitates the insertion and withdrawal of the medical device without causing damage to surrounding tissues or structures.

It will be appreciated from further reading of the following description that the medical device of the present invention is simple in structure and is therefore economical to produce.

With more particular reference to the first embodiment of Figures 1 to 10, the variant of Figures 23 to 27 and the embodiment of Figures 32 to 37A-37C, it can be noted that at the end 5A, 5A*, 105A of the second portion, the end of the elongated rod member 5, 5*, 105 extends substantially perpendicular to the first direction a1, i.e., along a second direction a2 parallel to the z-axis. In other words, the angle α2 depicted in Figures 3, 23 and 32 is substantially 90°.

In the illustrated example, the second portion of the elongated rod member 5, 5*, 105 comprises a single curved portion 5a, 5a*, 105a extending an angle α1 (see FIG. 2, which applies by analogy to the variants of FIGS. 23 to 27 and the embodiments of FIGS. 32 to 37A-37C), the angle α1 exceeding 60°, and the radius of curvature R1 of the curved portion 5a, 5a*, 105a being approximately 30 mm to 45 mm. By way of example, the angle α1 and the radius of curvature R1 may be selected to be approximately equal to 68° and 37 mm, respectively, which values should not be considered as limiting the scope of the invention. In this case, it is understood that at the end 5A, 5A*, 105A of the second portion, the end of the elongated rod member 5, 5*, 105 is bent relative to the end of the curved portion 5a, 5a*, 105a, the angle of the bend being approximately 20°, so that the end extends substantially perpendicular to the first direction a1.

The arcuate shape shown allows the instrument to be introduced under or against the structure to be released in the ultrasound field without any interference between the handle portion of the instrument and the ultrasound probe during the entire procedure. This shape also allows the instrument to be withdrawn without the risk of inadvertent damage to the surrounding soft tissue.

As a further illustration, the length L0 of the handle portion 2, 200 along the y-axis may be approximately 50 mm, while the total length L1 of the elongated rod member 5, 5*, 105 along the y-axis may be approximately 90 mm.

The length L2 may be approximately 5 mm (or greater).

With more particular reference to the other embodiments of FIGS. 11 to 20 , 28 to 31 and 38 to 43A-43C , it can be noted that the second portion of the elongated rod member 50 , 50 *, 150 comprises a plurality (i.e., three) of curved portions 50 a , 50 b , 50 c , 50 a * , 50 b * , 50 c * , 150 a , 150 b , 150 c , each extending at an angle β1 , β2 , β3 (see FIG. 12 , which applies by analogy to the variants of FIGS. 28 to 31 and the embodiments of FIGS. 39 to 43A-43C ), the angles β1 , β2 , β3 not exceeding 40°. By way of example, the angles β1 , β2 and β3 may be selected to be approximately equal to 35°, again, this value not being considered as limiting the scope of the invention.

According to this other embodiment, the three curved portions 50a, 50b, 50c, 50a*, 50b*, 50c*, 150a, 150b, 150c are separated by two substantially rectilinear portions having a length L2', L2**, L3', L3** of about 15 to 25 mm. For example, the lengths L2', L2** and L3', L3** are 22 mm and 17 mm, respectively.

As a further illustration, the length L0' of the handle portion 20, 200* along the y-axis can be approximately 25 mm to 35 mm, while the length L1' of the first straight portion of the elongated rod member 50, 50*, 150 can be approximately 30 mm. At the end 50A, 50A*, 150A of the elongated rod member 50, 50*, 150, the length L4', L4** of the end can also be approximately 5 mm (or less). In the variation of Figures 28 to 31, this length L4' can be reduced to, for example, approximately 2 mm to 3 mm.

With regard to the embodiments of Figures 11 to 20, Figures 28 to 31 and Figures 38 to 43A-43C, it can be noted that at the end 50A, 50A*, 150A of the second portion, the end of the elongated rod member 50, 50*, 150 extends along a second direction a2' substantially perpendicular to the first direction a1', but at an angle β4, as shown in Figures 13, 28 and 38, which is approximately 105° in this case.

The angled shape shown similarly allows the instrument to be introduced into the ultrasound field under or against the structure to be released without any interference between the handle portion of the instrument and the ultrasound probe during the entire procedure. This shape also allows the instrument to be withdrawn without the risk of inadvertent damage to the surrounding soft tissue.

Preferably, the elongated rod member is provided with a plurality of markings, which are designed to be discernible under ultrasound examination. Such markings are illustrated, for example, in Figures 2 to 5, 13, 23 to 25, 28, 29 and 32 to 43A-43C, and are identified by reference numerals 7, 70, 7*, 70*, 700 and 700*, respectively. These markings 7, 70, 7*, 70*, 700, 700* can be embossed in particular and can be conveniently distributed on the second part of the elongated rod member 5, 50, 5*, 50*, 105, 150, thereby allowing the surgeon to accurately monitor the position of the medical device when performing a percutaneous release procedure with the help of ultrasound examination. In the ultrasonic field, relative to the ultrasonic probe, the alignment markings 7, 70, 7*, 70*, 700, 700* can in particular ensure the correct and precise positioning of the medical device in the area to be treated. In this case, it is particularly contemplated to use the relevant markers 7, 70, 7*, 70*, 700, 700* to automatically locate and detect the orientation of the medical device in the ultrasound image and provide visual assistance to the surgeon. If desired, such visual assistance may also include superimposing a virtual representation of the medical device on the ultrasound image in real time.

Preferably, as schematically illustrated in Figures 23 to 25, 28, 29 and 32 to 43A-43C, the size and/or distribution of the markings 7*, 70*, 700, 700* along the elongated rod members 5*, 50*, 105, 150 may be uneven to facilitate identification of the relative orientation of the medical device under ultrasonic examination.

Advantageously, as shown in FIGS. 1 to 10 (see also FIGS. 23 to 27 ), a visual mark 3 (e.g., a laser mark) may be provided on the handle portion 2 to likewise identify the orientation of the medical device when performing an operation. In the case of the embodiment of FIGS. 32 to 37A-37C , a similar visual mark 300 is provided, which mark 3, 300 may be provided in particular on the inner face 2A, 200A of the handle portion 2, 200, the mark being oriented in the same direction as the second portion of the elongated rod member 5, 5*, 105. Although not specifically illustrated in FIGS. 11 to 20 , 28 to 31 and 38 to 43A-43C , similar visual marks may be provided on the inner face 20A, 200A* of the handle portion 20, 200* of the medical device 10, 10*, 110.

Preferably, the elongated rod member 5, 50, 500, 5*, 50*, 105, 150 has a substantially circular cross section upstream of the end 5A, 50A, 500A, 5A*, 50A*, 105A, 150A. The diameter D1, D1', D1*, D1** of the elongated rod member 5, 50, 500, 5*, 50*, 105, 150 may be, in particular, about 1 mm to 2 mm. For example, the diameter D1, D1* of the elongated rod member 5, 5*, 105 is about 1.5 mm, while the diameter D1', D1** of the elongated rod member 50, 50*, 150 is about 1.3 mm.

In the illustrations of Figures 1 to 31, it is understood that the elongated rod members 5, 50, 500, 5*, 50* are shown as solid and non-hollow. However, it is contemplated that a hollow rod member may be used instead (similar to the embodiments discussed with reference to Figures 32 to 43A-43C), which would provide the ability to detect possible bleeding through the relevant rod cavity in the event of a damaged blood vessel, and/or to inject a local anesthetic using a special syringe inserted into the relevant rod cavity. In this case, it is advantageous to further provide the handle of the medical device with a corresponding cavity that is also connected to the rod cavity, for example to allow injection of a local anesthetic. However, in the case of the embodiments discussed with reference to Figures 1 to 31, the use of solid and non-hollow rod members is still particularly advantageous because the medical device is simpler and more cost-effective to produce.

In the case of the embodiment of Figures 32 to 43A-43C, the elongated rod members 105, 150 preferably comprise hollow tube members as described above, which facilitates the formation of the flattened portion 106, 160, since such flattened portion can be produced simply by extruding the free end of the hollow tube member 105.1, 150.1. Nevertheless, solid and non-hollow rod members are still conceivable.

The medical device of the invention can be used in particular for the purpose of performing percutaneous release procedures on the upper or lower limbs, in particular with the aid of ultrasound examination. However, other uses are also conceivable.

Surgical release of the transverse carpal ligament (TCL) using, for example, the medical device 1, 1* or 100 as described above is essentially performed as follows:

1. Patient placement

The patient is in a supine position with the arm placed on a side table. After disinfection of the arm (from fingertips to elbow), a sterile drape is placed. Sterile ultrasound gel and cover for the ultrasound probe are applied. The procedure starts with the placement of the ultrasound probe at the base of the patient's palm. Different anatomical structures are identified in the coronal and sagittal planes: flexor tendons, radial artery, ulnar artery, superficial palmar arch, median and ulnar nerves, median motor branches and branches of Berrettini (if present). The flexor retinaculum (transverse carpal ligament - TCL) is also identified. All potential structures that could hinder the percutaneous release are excluded (intraductal masses, ectopic muscles or arteries, etc.).

2. Local anesthesia

Under ultrasound guidance, insert an 18-gauge needle 1 cm proximal to the palmar wrist crease between the ulnar artery and the median nerve. Care is taken to avoid entering the Guyon canal. Under ultrasound guidance, 3 ml of lidocaine is injected into the carpal tunnel and 3 ml of lidocaine is further injected subcutaneously above the TCL from its proximal edge to its distal edge. The latter injection may be somewhat painful.

3. Preparation of the device entry point

A 14-gauge needle is passed through the same skin entry point at a 35° angle in the sagittal plane and between the ulnar artery and median nerve, through the palmar carpal ligament to reach the carpal tunnel. Once in the carpal tunnel, the needle tip can be accurately identified by slightly rotating its bevel.

The 14-gauge needle is then withdrawn and a round-tipped probe is introduced into the carpal tunnel through the entry point. The probe allows palpation of the TCL from its proximal end to its distal edge, defining the path of the posterior segment. The probe is placed just lateral to the hook of the hook. The probe cannot reach the subcutaneous plane from the carpal tunnel. During this step, the ultrasound probe is placed alternately longitudinally and transversely to obtain a long axial view.

4. Insert the instrument through the entry point

Maintaining longitudinal visualization, the rounded tip stylet is withdrawn and the medical device described above (also referred to as a carpal tunnel release ultrasound instrument, or CTrSI) is introduced through the entry point under ultrasonic control. In the example shown in FIGS. 44A and 44B , the medical device 100 is used and the flattened portion 106 is first introduced, with the flattened portion 106 oriented in the palm of the hand with the leading edge 106A oriented substantially parallel to the plane of the TCL.

Once the tip of the medical device 100 passes through the palmar carpal ligament, the device 100 is rotated 90° clockwise, allowing the flattened portion 106 and leading edge 106A of the device 100 to rotate in the sagittal plane, substantially perpendicular to the plane of the TCL, as schematically shown in Figures 45A and 45B.

5. Cutting of the transverse carpal ligament

The proximal portion of the palmar carpal ligament is first processed and gradually cut in an antegrade manner. At every millimeter, the tip of the leading edge 106A is introduced between the tendon and the TCL for a hooking motion. As schematically shown in Figures 46A to 46C, the TCL is then gradually cut in the same antegrade manner by manipulating the instrument 100 to induce a swinging motion of its leading edge 106A from the dorsal to the palmar portion of the TCL.

At the beginning of the TCL release, a snapping sound may be heard based on the stiffness of the TCL. The release is performed at the level of the safe zone located lateral to the hook of the hook with continuous ultrasonic control of the position of the ulnar artery and the median nerve medially and laterally, respectively. The cut of the TCL is performed very obliquely from dorsal to volar and from medially to laterally. Throughout the procedure, short axial views are performed regularly to control the position of the instrument 100. Due to the close proximity of the volar superficial carpal arch, the distal edge of the TCL can be released very carefully with accurate identification of the instrument tip and the arch with the ultrasonic probe. At the end of the procedure, the tip of the instrument 100 is used as a hook to assess the completion of the release. Figure 47 schematically illustrates the withdrawal of the instrument 100 after the release of the TCL is completed.

6. Confirm that the release is complete

The instrument 100 is withdrawn and the rounded tip probe is reintroduced to palpate the remainder of the TCL and confirm that release is complete, which can be verified by observing that the probe can be moved from the carpal tunnel to the subcutaneous plane without any resistance.

7. Postoperative Care

A compression dressing is placed over the introduction site and over the carpal tunnel. This dressing is completely removed 12 hours after the procedure and then no more dressing is needed. The day after the procedure the patient is allowed to perform all his/her daily activities without any restrictions. During the first ten days after the procedure the patient is advised to wear a sling when not using the hand and to actively move the fingers to prevent swelling of the fingers and possible concurrent regional pain syndrome (CRPS).

Surgical release of the A1 pulley using, for example, the medical device 10, 10* or 110 described above is performed essentially as follows:

1. Patient placement

The patient is in a supine position with the arm placed on a side table. After disinfection of the arm (from fingertips to elbow), a sterile drape is placed. Sterile ultrasound gel and cover for the ultrasound probe are applied. At the beginning of the procedure, the ultrasound probe is placed on the palm, just proximal to the metacarpophalangeal (MCP) joint. Different anatomical structures are identified in the coronal and sagittal planes: flexor tendons, digital collateral nerves and arteries, digital pulleys. In particular, the A1 pulley is identified and its thickness is measured.

2. Local anesthesia

A 22-gauge curved needle is inserted just distal to the MCP skin fold, and 2 to 3 ml of lidocaine is injected under ultrasound guidance just above the A1 pulley and into the finger cannula. The patient is then asked to fully flex his/her finger to allow visualization of the trigger finger phenomenon, tendon gliding, and range of motion (ROM) of the finger joint. Once the pain subsides, the trigger finger and irregular tendon gliding are usually better visualized than when the patient is not anesthetized.

3. Preparation of the device entry point

A 14-gauge needle is introduced through the same skin entry point and finger cannulated, just distal to the A1 pulley. The needle tip can be accurately identified by gently turning the bevel of the needle tip.

4. Insert the instrument through the entry point

The 14-gauge needle is withdrawn and the medical device described above (also referred to as a trigger finger release ultrasonic instrument, or TFrSI) is introduced through the same entry point under ultrasonic control. In the illustrated example shown in FIG48A , the medical device 110 is used and the flattened portion 160 is introduced first, with the flattened portion 160 oriented in the palm of the hand, with the leading edge 160A oriented substantially parallel to the palmar plane of the pulley.

When the tip of instrument 110 arrives against the A1 pulley, instrument 110 makes a 90° clockwise rotation, allowing the flattened portion 160 and leading edge 160A of instrument 110 to rotate in the sagittal plane, substantially perpendicular to the palmar plane of the A1 pulley, as schematically illustrated in FIG. 48B .

5. Cutting of A1 pulley

At every millimeter, the tip of the leading edge 160A is introduced between the tendon and the pulley and cut by a hooking motion. As schematically shown in Figures 49A and 49B, the A1 pulley is gradually cut in a reverse manner by operating the instrument 110 to induce a swinging motion of its leading edge 160A from the back of the A1 pulley to the palm. The release is performed at the level of the safe zone located at the apex of the pulley in the coronal plane. Throughout the procedure, short axial views are taken regularly to control the position of the instrument 110. At the end of the procedure, the tip of the instrument 110 is used as a hook to ensure that the entire A1 pulley has been completely released.

6. Confirm that the release is complete

The instrument 110 is withdrawn and the patient is asked to fully flex the finger to ensure that the trigger finger has disappeared. Figure 50 schematically illustrates the withdrawal of the instrument 110 after the release of the A1 pulley is completed.

7. Postoperative Care

A compression dressing is placed and 12 hours after the procedure, the dressing is completely removed. No more dressing is required after that. The day after the procedure, the patient can carry out all his/her daily activities without any restrictions. Passive proximal interphalangeal (PIP) hyperextension exercises are recommended to prevent post-PIP muscle atrophy.

Surgical release procedures are very similar in treating conditions that commonly affect the upper extremity, such as Quervain tendinopathy (involving the cutting of the localized diaphragm) and tennis elbow (lateral epicondyle).

Various modifications and/or improvements may be made to the embodiments described above without departing from the scope of the invention as defined by the appended claims. In particular, although embodiments of the invention have been described for the purpose of performing percutaneous carpal tunnel release and percutaneous A1 pulley release, the invention is generally applicable to any percutaneous release procedure, whether in the upper or lower extremities, or other parts of the body, such as the neck or spine.

Furthermore, although the embodiments of Figures 1 to 31 show medical devices in which the inclined end presents one or more completely flat inclined surfaces, the claims should be interpreted as including all variations in which each inclined surface is substantially flat or presents a slight curvature, whether slightly concave or convex. By convention, the plane of an inclined surface can generally be defined as the plane closest to the inclined surface.

Medical device of the present invention can be specially designed for single use.In this respect, and in order to prevent the reuse of medical device, handle part can be specially designed to melt under the situation of re-sterilization, for example by using thermoplastic material.

Reference numerals and reference signs used herein

1 Medical Device According to the Present Invention (First Embodiment)

2 Handle portion of medical device 1, 1*

2A Inner surface of handle part 2

2B A mounting hole provided on the handle portion 2 for fixing the elongated rod members 5, 5* (e.g. by mechanical press-in insertion and/or gluing)

3 Marking (eg laser marking) on the inner surface 2A of the handle portion 2

5 The elongated rod member of the medical device 1 extending in the defined plane P0

5a (single) bent portion of the elongated rod member 5

5A End of (the second part of) the elongated rod member 5

6 The inclined end, located at the end 5A of the elongated rod member 5, is designed as a cutting device for cutting off tissue

6A Inclined surface of inclined end 6

7 Markings (e.g. embossing) provided along the elongated rod member 5 and designed to be discernible under ultrasonic inspection

1* Medical device according to the present invention (variation of the first embodiment)

5* The elongated rod member of the medical device 1* extending in the defined plane P0

5a* (single) bent portion of the elongated rod member 5*

5A* End of (the second part of) the elongated rod member 5*

6* An inclined end, located at the end 5A* of the elongated rod member 5*, is designed as a cutting device for cutting off tissue

6A* Inclined surface of inclined end 6*

7* Markings (e.g. embossing) provided along the elongated rod member 5*, designed to be discernible under ultrasonic inspection

100 Medical device according to the present invention (embodiment with flattened end)

200 Handle portion of medical device 100

200A Inner surface of handle portion 200

300 Marking (eg, laser marking) located on the inner surface 200A of the handle portion 200

105 The elongated rod member of the medical device 100 extending within the defined plane P0

105.1 Hollow tube components

105.1A End of hollow tube member 105.1 before flattening

105.2 Inner member inserted into a portion of the hollow tube member 105.1

105a (single) bent portion of the elongated rod member 105

105A End of (the second part of) the elongated rod member 105

106 is a flattened portion of the free end of the elongated rod member 105, located at the end 105A of the elongated rod member 105, and is designed to be a cutting device for severing tissue.

106A tapered leading edge (cutting edge) of flattened portion 106

700 markings (e.g., embossing) disposed along the elongated rod member 105 and designed to

Can be identified by ultrasound examination

D1 diameter of the elongated rod member 5, 5* upstream of the end 5A, 5A* (eg, about 1.5 mm)

L0 Length of handle part 2 along the y axis

L1 Total length of the elongated rod member 5 along the y axis

L2 The length of the end portion of the elongated rod member 5 at the end 5A along the z axis

D1* outer diameter of the elongated rod member 105 upstream of the end 105A (e.g., about 1.5 mm)

La* Total length of the hollow tube member 105.1 before forming

Lb* Length of the end portion of the hollow tube member 105.1 along the z-axis before flattening at the end 105.1A.

R1 Curvature radius of curved portion 5a, 5a*, 105a

a1 General extension direction of the first portion of the elongated rod member 5, 5*, 105 ("first direction")

a2 The general extension direction of the end portion at the distal end 5A, 5A*, 105A of the elongated member 5, 5*, 105 ("second direction")

α1 Angle of the curved parts 5a, 5a*, 105a

α2 Total curvature angle of the elongated rod member 5, 5*, 105, or the angle formed between the first direction a1 and the second direction a2 (eg, ˜90°)

θ1 Angle of the inclined surface 6A relative to the defined plane P0

θ1* Angle of the inclined surface 6A* relative to the defined plane P0

δ1 Surface angle at the end 105.1A of the hollow tube member 105.1 before forming and flattening

w1 Width of the flattened portion 106 measured in plane P0 (less than 2.5 mm, for example 2.3 mm)

t1 thickness of the flattened portion 106 measured perpendicular to the plane P0 (less than 0.5 mm, for example 0.3 mm)

10 Medical device according to the present invention (second embodiment)

20 Handle portion of medical device 10, 10*

20A Inner surface of handle portion 20

20B A mounting hole provided on the handle portion 20 for fixing the elongated rod members 50, 50* (eg, by mechanical press-in insertion and/or gluing)

50 The elongated rod member of the medical device 10 extending within the defined plane P0

50a (first) bent portion of the elongated rod member 50

50b (second) curved portion of the elongated rod member 50

50c (third) bent portion of the elongated rod member 50

50A End of (the second portion of) the elongated rod member 50

60 The inclined end, located at the end 50A of the elongated rod member 50, is designed to be a cutting device for cutting off tissue.

60A Inclined surface of inclined end 60

70 Markings (e.g., embossing) disposed along the elongated rod member 50 and designed to be discernible under ultrasonic inspection

10* Medical device according to the present invention (variation of the second embodiment)

50* The elongated rod member of the medical device 10* extending within the defined plane P0

50a* (first) bent portion of the elongated rod member 50*

50b* (Second) curved portion of the elongated rod member 50*

50c* (third) curved portion of the elongated rod member 50*

50A* End of (the second portion of) the elongated rod member 50*

60* An inclined end, located at the end 50A* of the elongated rod member 50*, is designed as a cutting device for cutting off tissue

60A* Inclined surface of inclined end 60*

70* Marking (e.g., embossing) disposed along the elongated rod member 50*, designed to be discernible under ultrasonic inspection

110 Medical device according to the present invention (another embodiment with flattened end)

200* Handle portion of medical device 110

200A* Inner surface of handle part 200*

150 The elongated rod member of the medical device 110 extending within the defined plane P0

150.1 Hollow tube components

105.1A End of hollow tube member 105.1 before flattening

150.2A (first) side bevel, provided on the leading edge of the end 150.1A of the hollow tube member 150.1 before flattening

150.2B (second) side bevel, provided on the leading edge of the end 150.1A of the hollow tube member 150.1 before flattening

150a (first) curved portion of the elongated rod member 150

150b (second) curved portion of the elongated rod member 150

150c (third) bent portion of the elongated rod member 150

150A End of (the second portion of) the elongated rod member 150

160 The flattened portion of the free end of the elongated rod member 150, located at the distal end 150A of the elongated rod member 150, is designed to be a cutting device for severing tissue.

160A tapered leading edge (cutting edge) of flattened portion 160

700* Marking (e.g., embossing) disposed along the elongated rod member 150, designed to be discernible under ultrasonic inspection

D1' diameter of the elongated rod member 50, 50* upstream of the end 50A, 50A* (e.g., about 1.3 mm)

L0' Length of the handle portion 20 along the y-axis

L1' is the length of the first portion of the elongated rod member 50, 50* along the y-axis

L2' The length of the straight line between the first curved portion 50a, 50a* and the second curved portion 50b, 50b*

L3' The length of the straight portion between the second portion 50b, 50b* and the third curved portion 50c, 50c*

L4' is the length of the end portion of the elongated rod member 50, 50* at the distal end 50A, 50A*

D1** Outer diameter of the elongated rod member 150 upstream of the end 150A (e.g., about 1.3 mm)

D2** Inner diameter of the elongated rod member 150 upstream of the end 150A (e.g., about 0.9 mm)

La** Total length of the hollow tube component 150.1 before forming

L1** Length of the first portion of the elongated rod member 150 along the y-axis

L2** The length of the straight portion between the first curved portion 150a and the second curved portion 150b

L3** The length of the straight portion between the second curved portion 150b and the third curved portion 150c

L4** Length of the end of the elongated rod member 150 at the distal end 150A

a1' The general extension direction of the first portion of the elongated rod member 50, 50*, 150 ("first direction")

a2' is the general direction of extension of the end portion at the distal end 50A, 50A*, 105A of the elongated member 50, 50*, 105 (the "second direction")

β1 Angle of the first curved portion 50a, 50a*, 105a

β2 Angle of the second curved portion 50b, 50b*, 105b

β3 Angle of the third curved portion 50c, 50c*, 105c

β4 Total curvature angle of the elongated rod member 50, 50*, 150, or the angle formed between the first direction a1' and the second direction a2' (e.g., 105°)

θ2 Angle of the inclined surface 60A relative to the defined plane P0

θ2* Angle of the inclined surface 60A* relative to the defined plane P0

δ1' The surface angle at the end 150.1A of the hollow tube member 150.1 before forming and flattening

δ2' Angle formed by side slopes 150.2A and 150.2B

w2 Width of the flattened portion 160 measured in plane P0 (less than 2.5 mm, e.g. 1.8 mm)

t2 thickness of the flattened portion 160 measured perpendicular to the plane P0 (less than 0.5 mm, for example 0.4 mm)

500 An elongated rod member of a medical device extending within a defined plane P0

500A End of (the second portion of) the elongated rod member 500

600 The inclined end, located at the end 500A of the elongated rod member 500, is designed to be a cutting device for cutting off tissue.

600A (first) inclined surface of the inclined end 600

610A (Second) inclined surface of the inclined end 600

615A (first) side bevel, disposed on the leading edge of the beveled end 600 and defining a corresponding (first) cutting edge 620A

615B (second) side bevel, disposed on the leading edge of the inclined end 600 and defining a corresponding (second) cutting edge 620B

620A (first) cutting edge, which is located at the leading edge of the inclined end 600

620B (second) cutting edge, which is located at the leading edge of the inclined end 600

γ1 Angle formed by the side slopes 615A and 615B

θ3 Angle of the inclined surface 600A relative to the defined plane P0

θ4 Angle of the inclined surface 610A relative to the defined plane P0

615A* (first) side bevel, disposed on the leading edge of the inclined end 6*, and defining a corresponding (first) cutting edge 620A*

615B* (second) side bevel, disposed on the leading edge of the inclined end 6* and defining a corresponding (second) cutting edge 620B*

620A* (first) cutting edge is located at the leading edge of the inclined end 6*

620B* (second) cutting edge is located at the leading edge of the inclined end 6*

γ1* Angle formed by side slopes 615A* and 615B*

615A** (first) side bevel, disposed on the leading edge of the inclined end 60*, and defining a corresponding (first) cutting edge 620A**

615B** (second) side bevel, disposed on the leading edge of the inclined end 60* and defining a corresponding (second) cutting edge 620B**

620A** (first) cutting edge, which is located at the leading edge of the inclined end 60*

620B** (second) cutting edge, located at the leading edge of the beveled end 60*

γ2* Angle formed by cutting edges 620A**, 620B**

1000 Ultrasonic Probe

x, y, z Cartesian coordinate system

GX busbar, long rod members 5, 50, 5*, 50*, 500, 105, 150 extend along the busbar

P0 defines a plane in which the elongated rod members 5, 50, 5*, 50*, 500, 105, 150 extend.

P plane of inclined surface 6A

P' plane of inclined surface 60A

P”, P”’ plane of inclined surfaces 600A, 610A

P* plane of inclined surface 6A*

P** Plane of inclined surface 60A*.

Claims (36)

1. A medical device (1; 10; 1*; 10*) for use in a percutaneous release procedure, comprising a handle portion (2; 20) designed to allow the medical device (1; 10; 1*; 10*) to be handled, oriented and manipulated by a surgeon, and an elongated rod member (5; 50; 500; 5*; 50*) fixed to the handle portion (2; 20) and extending substantially within a defined plane (P0), wherein a first portion of the elongated rod member (5; 50; 500; 5*; 50*) extends away from the handle portion (2; 20) substantially along a first direction (a1; a1') within the defined plane (P0), wherein a second portion of the elongated rod member (5; 50; 500; 5*; 50*) located downstream of the first portion is bent and/or folded within the defined plane (P0), wherein the free end of the elongated rod member (5; 50; 500; 5*; 50*) is shaped, at the end (5A; 50A; 500A; 5A*; 50A*) of the second portion as an inclined end (6; 60; 600; 6*; 60*) presenting an inclined surface (6A; 60A; 600A, 610A; 6A*; 60A*), the inclined end (6; 60; 600; 6*; 60*) being designed to be used as a cutting device for severing tissue, the inclined surface (6A; 60A; 600A, 610A; 6A*; 60A*) being inclined relative to the defined plane (P0), And wherein the end of the elongated rod member (5; 50; 500; 5*; 50*) extends substantially perpendicularly to the first direction (a1; a1') at the end (5A; 50A, 500A, 5A*; 50A*) of the second part. 2. The medical device (1; 10; 1*; 10*) according to claim 1, wherein the inclination angle (θ1; θ2; θ3, θ4; θ1*; θ2*) of the plane (P; P’; P”, P”’; P*; P**) including the inclined surface (6A; 60A; 600A, 610A; 6A*; 60A*) relative to the defined plane (P0) is 10° to 40°. 3. The medical device (1; 10; 1*; 10*) according to claim 2, wherein the inclination angle (θ1; θ2; θ3, θ4; θ1*; θ2*) is 15° to 30°. 4. The medical device according to any one of claims 1-3, wherein the inclined end (600) presents at least two inclined surfaces (600A, 610A), and the at least two inclined surfaces (600A, 610A) have different inclination angles (θ3, θ4). 5. The medical device (1*; 10*) according to any one of claims 1-3, wherein, at the extreme distal end of the inclined end (600; 6*; 60*), the leading edge of the inclined end (600; 6*; 60*) is provided with at least one side bevel (615A, 615B; 615A*; 615B*; 615A**, 615B**) defining a cutting edge (620A, 620B; 620A*, 620B*; 620A**, 620B**). 6. The medical device (1; 10; 1*; 10*) according to any one of claims 1 to 3, wherein the elongated rod member (5; 50; 500; 5*; 50*) is solid and non-hollow. 7. The medical device (1; 10; 1*; 10*) according to any one of claims 1 to 3, wherein the elongated rod member (5; 50; 500; 5*; 50*) extends along a generatrix (GX), and wherein a lateral width of the elongated rod member (5; 50; 500; 5*; 50*) measured at any point along the generatrix (GX) up to and including the end (5A; 50A; 500A; 5A*; 50A*) of the second portion does not exceed 2 mm. 8. A medical device (100; 110) for use in a percutaneous release procedure, comprising a handle portion (200; 200*) designed to allow the medical device (100; 110) to be manipulated, oriented and steered by a surgeon, and an elongated rod member (105; 150) secured to the handle portion (200; 200*) and extending substantially within a defined plane (P0), wherein a first portion of the elongated rod member (105; 150) extends substantially in a first direction (a1; a1') away from the handle portion (200; 200*) within the defined plane (P0), wherein a second portion of the elongated rod member (105; 150) located downstream of the first portion is bent and/or folded within the defined plane (P0), wherein the free end of the elongated rod member (105; 150) at the end (105A; 150A) of the second portion is flattened to form a flattened portion (106; 160), the flattened portion (106; 160) being designed to be used as a cutting device for severing tissue, the flattened portion (106; 160) extending substantially parallel to the defined plane (P0), And wherein the end of the elongated rod member (105; 150), at the end (105A; 150A) of the second portion, extends substantially perpendicular to the first direction (a1; a1'). 9. The medical device (100; 110) according to claim 8, wherein the flattened portion (106; 160) extends substantially within the defined plane (P0). 10. The medical device (100; 110) according to claim 8 or 9, wherein the flattened portion (106; 160) is configured to present a tapered leading edge (106A; 160A), and the tapered leading edge (106A; 160A) serves as a cutting edge. 11. The medical device (100; 110) according to claim 8 or 9, wherein the flattened portion (106; 160) presents a thickness (t1; t2) less than 0.5 mm, the thickness being measured perpendicular to the defined plane (P0). 12. The medical device (100; 110) according to claim 8 or 9, wherein the flattened portion (106; 160) presents a width (w1; w2) not exceeding 2.5 mm, the width being measured in the defined plane (P0). 13. A medical device (100; 110) according to claim 8 or 9, wherein the elongated rod member (105, 150) extends along a generatrix (GX), and wherein a lateral width of the elongated rod member (105, 150) measured at any point along the generatrix (GX) up to but not including the end (105A; 150A) of the second portion does not exceed 2 mm. 14. The medical device (100; 110) according to claim 8 or 9, wherein the elongated rod member (105; 150) comprises a hollow tube member (105.1; 150.1), and wherein the flattened portion (106; 160) is a flattened free end of the hollow tube member (105.1; 150.1). 15. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the end of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) extends along a second direction (a2; a2’), and the angle (α2; β4) formed by the second direction relative to the first direction (a1; a1’) is included between 80° and 120°. 16. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the first portion of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) is a substantially straight portion. 17. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 16, wherein the first portion of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) has a length of 30 mm to 60 mm. 18. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the second part includes at least one curved portion (5a; 50a, 50b, 50c; 5a*, 50a*, 50b*, 50c*; 105a; 150a, 150b, 150c), and the angle (α1; β1, β2, β3) at which the at least one curved portion extends exceeds 30°. 19. The medical device (1; 1*; 100) according to claim 18, wherein the second portion comprises a single curved portion (5a; 5a*; 105a), the angle (α1) of which the single curved portion extends exceeds 60°. 20. The medical device (1; 1*; 100) according to claim 19, wherein the radius of curvature (R1) of the curved portion (5a; 5a*; 105a) is 30 mm to 45 mm. 21. The medical device (1; 1*; 100) according to claim 19 or 20, wherein the end of the elongated rod member (5; 5*; 105), at the end (5A; 5A*; 105A) of the second part, extends along a second direction (a2) perpendicular to the first direction (a1). 22. The medical device (10; 10*; 100) according to claim 18, wherein the second part comprises a plurality of curved portions (50a, 50b, 50c; 50a*, 50b*, 50c*; 150a, 150b, 150c), and the angle (β1, β2, β3) at which each curved portion extends does not exceed 40°. 23. The medical device (10; 10*; 110) according to claim 22, wherein the second portion comprises three curved portions (50a, 50b, 50c; 50a*, 50b*, 50c*; 150a, 150b, 150c). 24. The medical device (10; 10*; 110) according to claim 22 or 23, wherein the plurality of curved portions (50a, 50b, 50c; 50a*, 50b*, 50c*; 150a, 150b, 150c) are separated by substantially straight portions. 25. The medical device (10; 10*; 110) according to claim 24, wherein the straight portion separating the multiple curved portions (50a, 50b, 50c; 50a*, 50b*, 50c*; 150a, 150b, 150c) has a length (L2', L3'; L2**, L3**) of 15 mm to 25 mm. 26. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the elongated rod member (5; 50; 500; 5*; 50*; 105) is provided with a plurality of markings (7; 70; 7*; 70*; 700; 700*), which are designed to be discernible under ultrasonic examination. 27. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 26, wherein the marking (7; 70; 7*; 70*; 700; 700*) is embossed. 28. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 26, wherein the marking (7; 70; 7*; 70*; 700; 700*) is distributed on the second part of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150). 29. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 26, wherein the size and/or distribution of the markings (7; 70; 7*; 70*; 700; 700*) along the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) are non-uniform. 30. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the handle portion (2; 20; 200; 200*) is provided with a visual marking (3; 300). 31. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 30, wherein the visible mark (3; 300) is a laser mark. 32. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 30, wherein the visual mark (3; 300) is arranged on the inner surface (2A; 20A; 200A; 200A*) of the handle part (2; 20; 200; 200*); and the visual mark is oriented in the same direction as the second part of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150). 33. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the cross-section of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) has an area of no more than ⁵ mm2. 34. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 33, wherein the cross-section of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) has an area of no more than ² mm2. 35. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the diameter (D1; D1’; D1*; D1**) of the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) located upstream of the end (5A; 50A; 500A; 5A*; 50A*; 105A; 150A) is 1 mm to 2 mm. 36. The medical device (1; 10; 1*; 10*; 100; 110) according to claim 1 or 8, wherein the elongated rod member (5; 50; 500; 5*; 50*; 105; 150) has a substantially circular cross-section upstream of the end (5A; 50A; 500A; 5A*; 50A*; 105A; 150A).